INTERACTIONS No specific drug interaction studies have been performed.
Cysview is contraindicated in patients with: porphyria, gross hematuria, known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Do not use Cysview in patients with: porphyria, gross hematuria, known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives. ( 4 )
AND PRECAUTIONS Anaphylaxis: have trained personnel and therapies available. ( 5.1 ).
Failed
Detection: Cysview may not detect all malignant lesions. Always perform white light cystoscopy followed by blue light cystoscopy. Do not biopsy with blue light only. ( 5.2 ) False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy or chemotherapy. ( 5.3 )
5.1 Anaphylaxis Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview [ see Adverse Reactions (6.2) ]. Prior to and during use of the Cysview, have trained personnel and therapies available for the treatment of anaphylaxis.
5.2 Failed Detection Cysview may fail to detect some bladder tumors, including malignant lesions. Cysview is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer. Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light [ see Dosage and Administration (2.5) and Clinical Studies (14) ].
5.3 False Positive Fluorescence Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. In the controlled clinical studies, approximately 20% of the lesions detected only by blue light cystoscopy showed neither dysplasia nor carcinoma [ see Clinical Studies (14) ]. False positive fluorescence may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination, and recent BCG immunotherapy or intravesical chemotherapy. In a study of patients treated with recent BCG immunotherapy or intravesical chemotherapy, the rate of false positives with blue light was 55% between 6 weeks to 90 days and 41% after 90 days; the false positive rate was 53% and 33% at the respective time intervals with white light. The presence of urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. To enhance the diagnostic utility of Cysview with the Karl Storz D-Light C PDD System: ensure the bladder is emptied of urine prior to the instillation of fluids at cystoscopy; biopsy/resect bladder mucosal lesions only following completion of both white light and blue light rigid cystoscopy;